eRAD RIS 2.16

eRAD RIS 2.16 is a Class II device made by Erad, Inc., cleared under FDA 510(k) K120995 on 3 Dec 2012 and listed in FDA GUDID since 2 May 2016 (UDI-DI 00866994000231), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00866994000231 UDI-DI	Date2 May 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK120995	Date3 Dec 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00866994000231
FDA 510(k) database 510(k) number K120995

Across registries

2 registries list this device

FDA 510(k) K120995 decided 3 Dec 2012 Active
FDA GUDID UDI-DI 00866994000231 listed 2 May 2016 Listed

Timeline

2 dated events

3 Dec 2012 Cleared FDA 510(k) K120995
2 May 2016 Listed FDA GUDID 00866994000231

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: eRAD RIS
Generic name: Radiology information system application software
Model / reference: 2.16

Primary DI / UDI-DI: 00866994000231
510(k) Number: K120995
FDA product code: LLZ
GMDN term: Radiology information system application software

Device class: Class II
Regulation number: 892.2050
GUDID distribution status: In Commercial Distribution

Other devices from Erad, Inc.

eRAD RIS 4.22

Class I
eRAD PACS Evolution 8.0

Class II
eRAD RIS 3.18

Class II
eRAD PACS 7.3

Class II

See all devices from Erad, Inc. →

Properties

Serial number

Other properties (14, all answered No)